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4. Artificial intelligence in digital pathology: a diagnostic test accuracy systematic review and meta-analysis

Author

McGenity, Clare, Clarke, Emily L, Jennings, Charlotte, Matthews, Gillian, Cartlidge, Caroline, Freduah-Agyemang, Henschel, Stocken, Deborah D, and Treanor, Darren

Subjects
Physics - Medical Physics, Computer Science - Artificial Intelligence, Computer Science - Computer Vision and Pattern Recognition, Electrical Engineering and Systems Science - Image and Video Processing, Quantitative Biology - Quantitative Methods, I.2.1
Abstract

Ensuring diagnostic performance of AI models before clinical use is key to the safe and successful adoption of these technologies. Studies reporting AI applied to digital pathology images for diagnostic purposes have rapidly increased in number in recent years. The aim of this work is to provide an overview of the diagnostic accuracy of AI in digital pathology images from all areas of pathology. This systematic review and meta-analysis included diagnostic accuracy studies using any type of artificial intelligence applied to whole slide images (WSIs) in any disease type. The reference standard was diagnosis through histopathological assessment and / or immunohistochemistry. Searches were conducted in PubMed, EMBASE and CENTRAL in June 2022. We identified 2976 studies, of which 100 were included in the review and 48 in the full meta-analysis. Risk of bias and concerns of applicability were assessed using the QUADAS-2 tool. Data extraction was conducted by two investigators and meta-analysis was performed using a bivariate random effects model. 100 studies were identified for inclusion, equating to over 152,000 whole slide images (WSIs) and representing many disease types. Of these, 48 studies were included in the meta-analysis. These studies reported a mean sensitivity of 96.3% (CI 94.1-97.7) and mean specificity of 93.3% (CI 90.5-95.4) for AI. There was substantial heterogeneity in study design and all 100 studies identified for inclusion had at least one area at high or unclear risk of bias. This review provides a broad overview of AI performance across applications in whole slide imaging. However, there is huge variability in study design and available performance data, with details around the conduct of the study and make up of the datasets frequently missing. Overall, AI offers good accuracy when applied to WSIs but requires more rigorous evaluation of its performance., Comment: 26 pages, 5 figures, 8 tables + Supplementary materials

Published
2023

5. Conservative management versus tonsillectomy in adults with recurrent acute tonsillitis in the UK (NATTINA): a multicentre, open-label, randomised controlled trial

Author

Wilson, Janet A, O'Hara, James, Fouweather, Tony, Homer, Tara, Stocken, Deborah D, Vale, Luke, Haighton, Catherine, Rousseau, Nikki, Wilson, Rebecca, McSweeney, Lorraine, Wilkes, Scott, Morrison, Jill, MacKenzie, Kenneth, Ah-See, Kim, Carrie, Sean, Hopkins, Claire, Howe, Nicola, Hussain, Musheer, Mehanna, Hisham, Raine, Christopher, Sullivan, Frank, von Wilamowitz-Moellendorff, Alexander, and Teare, M Dawn

Published
2023
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6. Non‐invasive vagus nerve stimulation to reduce ileus after colorectal surgery: randomized feasibility trial and efficacy assessment (IDEAL Stage 2B).

Author

Chapman, Stephen J., Kowal, Mikolaj, Helliwell, Jack A., Lockwood, Sonia, Naylor, Maureen, Croft, Julie, Farley, Katherine, Stocken, Deborah D., and Jayne, David G.

Subjects
VAGUS nerve stimulation, MEDICAL personnel, PATIENT compliance, PROCTOLOGY, GASTROINTESTINAL surgery
Abstract

Aim: Ileus is characterized by a period of intestinal dysmotility after surgery, leading to vomiting and constipation. In preclinical models, vagus nerve stimulation reduces intestinal inflammation and prevents smooth muscle dysfunction, accelerating the return of gut function. This study explored the feasibility of a definitive trial of non‐invasive vagus nerve stimulation (nVNS) along with an early assessment of efficacy. Method: A multicentre, randomized feasibility trial (IDEAL Stage 2B) of self‐administered nVNS was performed. Patients undergoing colorectal surgery were randomized to nVNS or sham before and after surgery. Feasibility outcomes comprised assessments of recruitment, compliance, blinding and attrition. Clinical outcomes were measures of intestinal function and adverse events. All participants were followed up for 30 days. Interviews with patients and health professionals explored barriers to feasibility and perspectives around implementation. Results: In all, 125 patients were approached about the study and 97 (77.6%) took part. Across all randomized groups, the median compliance to treatment was 19 out of 20 stimulations (interquartile range 17–20). The incidence of adverse events was similar across groups. In this unpowered feasibility study, the time taken for the return of gut function (such as first passage of stool) was similar between nVNS and sham treatments. According to interviews, patients were highly motivated to use the device because it provided them with an opportunity to engage actively in their care. Health professionals were highly driven to tackle the problem of ileus. Conclusion: Powered assessments of clinical efficacy are required to confirm or refute the promise of nVNS, as already demonstrated in preclinical models. This feasibility study concludes that a definitive randomized assessment of the clinical benefits of nVNS is desired and feasible. [ABSTRACT FROM AUTHOR]

Published
2024
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8. Effectiveness of septoplasty compared to medical management in adults with obstruction associated with a deviated nasal septum: the NAIROS RCT

Author

Carrie, Sean, primary, Fouweather, Tony, additional, Homer, Tara, additional, O’Hara, James, additional, Rousseau, Nikki, additional, Rooshenas, Leila, additional, Bray, Alison, additional, Stocken, Deborah D, additional, Ternent, Laura, additional, Rennie, Katherine, additional, Clark, Emma, additional, Waugh, Nichola, additional, Steel, Alison J, additional, Dooley, Jemima, additional, Drinnan, Michael, additional, Hamilton, David, additional, Lloyd, Kelly, additional, Oluboyede, Yemi, additional, Wilson, Caroline, additional, Gardiner, Quentin, additional, Kara, Naveed, additional, Khwaja, Sadie, additional, Leong, Samuel Chee, additional, Maini, Sangeeta, additional, Morrison, Jillian, additional, Nix, Paul, additional, Wilson, Janet A, additional, and Teare, M Dawn, additional

Published
2024
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9. Pretreatment prediction of response to ursodeoxycholic acid in primary biliary cholangitis: development and validation of the UDCA Response Score

Author

Thomas, Caradog, Rahman, Meshbah, Yapp, Tom, Lye Ch'ng, Chin, Harrison, Melanie, Sturgess, Richard, Galaska, Roman, Healey, Chris, Whiteman, Jessica, Czaijkowski, Marek, Gray, Catherine, Gunasekera, Anton, Gyawli, Pranab, Premchand, Purushothaman, Mann, Steven, Elliott, Keith, Kapur, Kapil, Watson, Alan, Foster, Graham, Trembling, Paul, Subhani, Javaid, Harvey, Rory, McCorry, Roger, Adgey, Carolyn, Hobson, Lucie, Mulvaney-Jones, Caroline, Evans, Richard, Mathialahan, Thiriloganathan, Ramanaden, David, Gasem, Jaber, Van Duyvenvoorde, Greta, Shorrock, Christopher, Seward, Katie, Southern, Paul, Tibble, Jeremy, Penn, Ruth, Gorard, David, Maiden, Jane, Damant, Rose, Palegwala, Altaf, Jones, Susan, Alexander, Graeme, Mells, George, Sandford, Richard, Dolwani, Sunil, Prince, Martin, Silvestre, Valeria, Foxton, Matthew, Dungca, Eleanor, Mitchison, Harriet, Wheatley, Natalie, Gooding, Ian, Doyle, Helen, Karmo, Mazn, Kent, Melanie, Saksena, Sushma, Braim, Delyth, Patel, Minesh, Lord, Susan, Ede, Roland, Paton, Alison, Austin, Andrew, Lancaster, Nicola, Sayer, Joanna, Gibbins, Andrew, Hogben, Karen, Hovell, Chris, Fisher, Neil, Carter, Martyn, Koss, Konrad, Musselwhite, Janine, Muscariu, Florin, Piotreowicz, Andrzej, McKay, Alexandra, Grimley, Charles, Neal, David, Ting Tan, Lai, Lim, Guan, Brighton, Jacqueline, Foale, Carole, Ala, Aftab, Saeed, Athar, Flahive, Kerry, Wood, Gordon, Townshend, Paula, Ford, Chris, Brown, Jonathan, Kordula, Jean, Bowles, Jane, Wilkinson, Mark, Palmer, Caroline, Ramage, John, Gordon, Harriet, Featherstone, James, Ridpath, Jo, Ngatchu, Theodore, Levi, Sass, Shaukat, Syed, Sadeghian, Joy, Shidrawi, Ray, Williams, Bronwen, Abouda, George, Jones, Sarah, Duggan, Claire, Hynes, Abigail, Narain, Mark, Rees, Ian, Salam, Imroz, Crossey, Mary, Taylor-Robinson, Simon, Brown, Ashley, MacNicol, Carolyn, Williams, Simon, Wilhelmsen, Elva, Banim, Paul, Raymode, Parizade, Chilton, Andrew, Das, Debasish, Lee, Hye-Jeong, Curtis, Howard, Heneghan, Michael, Gess, Markus, Durant, Emma, Drake, IM, Bishop, Rebecca, Davies, Mervyn, Jones, Rebecca, Aldersley, Mark, Ncube, Noma, McNair, Alistair, Srirajaskanthan, Raj, Sen, Sambit, Casey, Rebecca, Bird, George, Mendall, Mike, Cowley, Caroline, Barnardo, Adrian, Kitchen, Paul, Yoong, Kevin, Amore, Kelly, Sirdefield, Dawn, Orpe, Jacky, Mathew, Ray, MacFaul, George, Wrigth, Aruna, Shah, Amir, Evans, Chris, Keggans, Janie, Bird, Bridget, Baxter, Gwen, Saha, Subrata, Pollock, Katharine, Hughes, Maggie, Bramley, Peter, Grieve, Emma, Young, Karin, Fraser, Andrew, Mukhopadhya, Ashis, Ocker, Kate, Mills, Peter, Hines, Francis, Shallcross, Chris, Wilkins, Joy, Grellier, Leonie, Campbell, Stewart, Martin, Kirsty, Bathgate, Andrew, Innes, Caron, Shepherd, Alan, Rushbrook, Simon, Valliani, Talal, Przemioslo, Robert, Fairlamb, Helen, Macdonald, Chris, Eastick, Anne, Metcalf, Jane, Tanqueray, Elizabeth, Shmueli, Udi, Holbrook, Becky, Davis, Andrew, Browning, Julie, Naqvi, Asifabbas, Walker, Kirsten, Lee, Tom, Verheyden, Juliette, Slininger, Susan, Ryder, Stephen D, Chapman, Roger, Collier, Jane, O'Donnell, Denise, Stafford, Lizzie, Williamson, Kate, Kent, Linda, Klass, Howard, Ninkovic, Mary, March, Linda, Cramp, Matthew, Simpson, Diane, Dickson, Christine, Sharer, Nicholas, Hayes, Maria, Goggin, Patrick, Quinne, Mary, Pearson, Sallyanne, Hoeroldt, Barbara, Jones, Linda, Wright, Alice, Booth, Jonathan, Loftus, Alison, Lipscomb, George, Dewhurst, Hannah, Gunter, Emma, Williams, Earl, Fouracres, Anna, Farrington, Liz, Graves, Lyn, Hussaini, Hyder, Stableforth, Bill, Marriott, Suzie, Ayres, Reuben, Leoni, Marina, Burroughs, Andrew, Marshall, Eileen, Thorburn, Douglas, Tyrer, David, Martin, Kate, Lombard, Martin, Patanwala, Imran, Dali-Kemmery, Lola, Lambourne, Victoria, Maltby, Julia, Vyas, Samir, Colley, Julie, Shinder, Bal, Singhal, Saket, Jones, Jayne, Mills, Marisa, Gleeson, Dermot, Carnahan, Mandy, Butterworth, Jeff, Boulton, Kerenza, Taylor, Natalie, George, Keith, Harding, Tim, Tregonning, Julie, Douglass, Andrew, Brown, Carly, Clifford, Gayle, Panter, Simon, Gocher, Denise, Shearman, Jeremy, Bray, Gary, Hamilton, Maria, Butcher, Graham, Forton, Daniel, Mclindon, John, Curtis, Janette, Das, Debashis, Shewan, Tracey, Cowan, Matthew, Whatley, Gregory, Nasseri, Mariam, Grover, Bob, Sivaramakrishnan, Nurani, Ducker, Samantha, Houghton, Kathryn, Jones, David, Griffiths, Laura, Tripoli, Sherill, Pitcher, Maxton, Shpuza, Ervin, White, Nikki, Ghosh, Deb, Douds, Andrew, Green, Marie, Brookes, Matthew, Cumlat, Lourdes, Wong, Voi Shim, Warner, Karen, Netherton, Kimberley, Mandal, Adtya, Jain, Snjiv, Gupta, Hemant, Sanghi, Pradeep, Pereira, Steve, Neuberger, James, Gunson, Bridget, Hirschfield, Gideon, Lim, Reina Teegan, Gallagher, Susan, Clement, Darren, Brind, Alison, Watts, Gill, Mupudzi, Mcdonald, Wright, Mark, Gitahi, Jane, Gordon, Fiona, Gocher, Denis, Unitt, Esther, Pateman, Hilary, Batham, Sally, Delahooke, Toby, Grant, Allister, Conder, Jill, Higham, Andrew, Cox, Mark, O'Donohoe, Lynn, Currie, Lynn, King, Alistair, Oblak, Metod, Collins, Carole, Whalley, Simon, Quinn, Marie, Baird, Yolanda, Amey, Isobel, Fraser, Jocelyn, Li, Andy, Cotterill, Donna, Bell, Andrew, Singhal, Amit, Gee, Ian, Greer, Sandra, Ang, Yeng, Ransford, Rupert, Allison, Joanna, Gotto, James, Dyer, Simon, Sweeting, Helen, Millson, Charles, Invernizzi, Pietro, Carbone, Marco, Cristoferi, Laura, Bonato, Giulia, Malinverno, Federica, Bernuzzi, Francesca, Alvaro, Domenico, Labbadia, Giancarlo, Bragazzi, Maria Consiglia, Andreone, Pietro, Muratori, Luigi, Azzaroli, Francesco, Floreani, Annarosa, Galli, Andrea, Tarocchi, Mirko, Giannini, Edoardo, Miele, Luca, Gasbarrini, Antonio, Grieco, Antonio, Marrone, Giuseppe, Donato, Maria Francesca, Valenti, Luca, Marra, Fabio, Marzioni, Marco, Maroni, Luca, Rigamonti, Cristina, Zuin, Massimo, Battezzati, Pier Maria, Picciotto, Antonino, Nardi, Alessandra, Flack, Steve, Carpino, Guido, Varvaropoulou, Nikoletta, Gavrila, Caius, Spicer, Ann, Badrock, Jonathan, Cardinale, Vincenzo, Ainsworth, Holly F, Heneghan, Michael A, Neuberger, James M, Donato, Maria F, Kirby, John, Mitchell-Thain, Robert, Sampaziotis, Fotios, Gaudio, Eugenio, Ronca, Vincenzo, Gerussi, Alessio, Stocken, Deborah D, Cordell, Heather J, Hirschfield, Gideon M, Alexander, Graeme J, Sandford, Richard N, Jones, David E, and Mells, George F

Published
2018
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12. Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial

Author

Carrie, Sean, primary, O’Hara, James, additional, Fouweather, Tony, additional, Homer, Tara, additional, Rousseau, Nikki, additional, Rooshenas, Leila, additional, Bray, Alison, additional, Stocken, Deborah D, additional, Ternent, Laura, additional, Rennie, Katherine, additional, Clark, Emma, additional, Waugh, Nichola, additional, Steel, Alison J, additional, Dooley, Jemima, additional, Drinnan, Michael, additional, Hamilton, David, additional, Lloyd, Kelly, additional, Oluboyede, Yemi, additional, Wilson, Caroline, additional, Gardiner, Quentin, additional, Kara, Naveed, additional, Khwaja, Sadie, additional, Leong, Samuel C, additional, Maini, Sangeeta, additional, Morrison, Jillian, additional, Nix, Paul, additional, Wilson, Janet A, additional, and Teare, M Dawn, additional

Published
2023
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13. Sorafenib in combination with transarterial chemoembolisation in patients with unresectable hepatocellular carcinoma (TACE 2): a randomised placebo-controlled, double-blind, phase 3 trial

Author

Meyer, Tim, Fox, Richard, Ma, Yuk Ting, Ross, Paul J, James, Martin W, Sturgess, Richard, Stubbs, Clive, Stocken, Deborah D, Wall, Lucy, Watkinson, Anthony, Hacking, Nigel, Evans, T R Jeffry, Collins, Peter, Hubner, Richard A, Cunningham, David, Primrose, John Neil, Johnson, Philip J, and Palmer, Daniel H

Published
2017
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14. Response by Gierula et al to Letter Regarding Article, “Personalized Rate-Response Programming Improves Exercise Tolerance After 6 Months in People With Cardiac Implantable Electronic Devices and Heart Failure: A Phase II Study”

Author

Gierula, John, Lowry, Judith E., Paton, Maria F., Cole, Charlotte A., Byrom, Rowenna, Koshy, Aaron A., Chumun, Hemant, Kearney, Lorraine C., Straw, Sam, Bowen, T. Scott, Cubbon, Richard M., Keenan, Anne-Maree, Stocken, Deborah D., Kearney, Mark T., and Witte, Klaus K.

Published
2020
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17. Effectiveness of GRACE risk score in patients admitted to hospital with non-ST elevation acute coronary syndrome (UKGRIS): parallel group cluster randomised controlled trial

Author

Gale, Chris P, primary, Stocken, Deborah D, additional, Aktaa, Suleman, additional, Reynolds, Catherine, additional, Gilberts, Rachael, additional, Brieger, David, additional, Carruthers, Kathryn, additional, Chew, Derek P, additional, Goodman, Shaun G, additional, Fernandez, Catherine, additional, Sharples, Linda D, additional, Yan, Andrew T, additional, and Fox, Keith, additional

Published
2023
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18. Data from Phase I Trial of Recombinant Modified Vaccinia Ankara Encoding Epstein–Barr Viral Tumor Antigens in Nasopharyngeal Carcinoma Patients

Author

Hui, Edwin P., primary, Taylor, Graham S., primary, Jia, Hui, primary, Ma, Brigette B.Y., primary, Chan, Stephen L., primary, Ho, Rosalie, primary, Wong, Wai-Lap, primary, Wilson, Steven, primary, Johnson, Benjamin F., primary, Edwards, Ceri, primary, Stocken, Deborah D., primary, Rickinson, Alan B., primary, Steven, Neil M., primary, and Chan, Anthony T.C., primary

Published
2023
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19. Supplementary Methods, Figures 1 - 2, Tables 1 - 3 from Phase I Trial of Recombinant Modified Vaccinia Ankara Encoding Epstein–Barr Viral Tumor Antigens in Nasopharyngeal Carcinoma Patients

Author

Hui, Edwin P., primary, Taylor, Graham S., primary, Jia, Hui, primary, Ma, Brigette B.Y., primary, Chan, Stephen L., primary, Ho, Rosalie, primary, Wong, Wai-Lap, primary, Wilson, Steven, primary, Johnson, Benjamin F., primary, Edwards, Ceri, primary, Stocken, Deborah D., primary, Rickinson, Alan B., primary, Steven, Neil M., primary, and Chan, Anthony T.C., primary

Published
2023
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20. Pathway Of Low Anterior Resection syndrome relief after Surgery (POLARiS) feasibility trial protocol: a multicentre, feasibility cohort study with embedded randomised control trial to compare sacral neuromodulation and transanal irrigation to optimised conservative management in the management of major low anterior resection syndrome following rectal cancer treatment

Author

Coxon-Meggy, Alexandra Harriet, primary, Vogel, Irene, additional, White, Judith, additional, Croft, Julie, additional, Corrigan, Neil, additional, Meggy, Alun, additional, Stocken, Deborah D, additional, Keller, Deborah, additional, Hompes, Roel, additional, Knowles, Charles H, additional, Quyn, Aaron, additional, and Cornish, Julie, additional

Published
2023
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21. Multicenter Randomized Trial of Intermittently Scanned Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Individuals With Type 2 Diabetes and Recent-Onset Acute Myocardial Infarction: Results of the LIBERATES Trial

Author

Ajjan, Ramzi A., primary, Heller, Simon R., additional, Everett, Colin C., additional, Vargas-Palacios, Armando, additional, Higham, Ruchi, additional, Sharples, Linda, additional, Gorog, Diana A., additional, Rogers, Alice, additional, Reynolds, Catherine, additional, Fernandez, Catherine, additional, Rodrigues, Pedro, additional, Sathyapalan, Thozhukat, additional, Storey, Robert F., additional, and Stocken, Deborah D., additional

Published
2022
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22. Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT

Author

Nugent, Michael, primary, Bryant, Valerie, additional, Butcher, Chrissie, additional, Fisher, Holly, additional, Gill, Sean, additional, Goranova, Rebecca, additional, Hiu, Shaun, additional, Lindley, Lyndsay, additional, O’Hara, James, additional, Oluboyede, Yemi, additional, Patterson, Joanne, additional, Rapley, Tim, additional, Robinson, Tomos, additional, Rousseau, Nikki, additional, Ryan, Vicky, additional, Shanmugasundaram, Ramkumar, additional, Sharp, Linda, additional, Smith Whelan, Ruby, additional, Stocken, Deborah D, additional, Ternent, Laura, additional, Wilson, Janet, additional, and Walker, Jenn, additional

Published
2022
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23. Progress by Collaboration: ESPAC Studies

Author

Sutton, Robert, Stocken, Deborah D., Dunn, Janet A., Hickey, Helen, Raraty, Michael G. T., Ghaneh, Paula, Buckels, John, Deakin, Mark, Imrie, Clement W., Friess, Helmut, Büchler, Markus W., Neoptolemos, John P., Johnson, C. D., and Imrie, C. W.

Published
2004
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25. Clinical and cost-effectiveness of Knee Arthroplasty versus Joint Distraction for Osteoarthritis (KARDS): protocol for a multicentre, phase III, randomised control trial

Author

Tassinari, Cerys Joyce, primary, Higham, Ruchi, additional, Smith, Isabelle Louise, additional, Arnold, Susanne, additional, Mujica-Mota, Ruben, additional, Metcalfe, Andrew, additional, Simpson, Hamish, additional, Murray, David, additional, McGonagle, Dennis G, additional, Sharma, Hemant, additional, Hamilton, Thomas William, additional, Ellard, David R, additional, Fernandez, Catherine, additional, Reynolds, Catherine, additional, Harwood, Paul, additional, Croft, Julie, additional, Stocken, Deborah D, additional, and Pandit, Hemant, additional

Published
2022
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26. Multicenter Randomized Trial of Intermittently Scanned Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Individuals With Type 2 Diabetes and Recent-Onset Acute Myocardial Infarction: Results of the LIBERATES Trial.

Author

Ajjan, Ramzi A., Heller, Simon R., Everett, Colin C., Vargas-Palacios, Armando, Higham, Ruchi, Sharples, Linda, Gorog, Diana A., Rogers, Alice, Reynolds, Catherine, Fernandez, Catherine, Rodrigues, Pedro, Sathyapalan, Thozhukat, Storey, Robert F., and Stocken, Deborah D.

Abstract

OBJECTIVE: To analyze the impact of modern glucose-monitoring strategies on glycemic and patient-related outcomes in individuals with type 2 diabetes (T2D) and recent myocardial infarction (MI) and assess cost effectiveness. RESEARCH DESIGN AND METHODS: LIBERATES was a multicenter two-arm randomized trial comparing self-monitoring of blood glucose (SMBG) with intermittently scanned continuous glucose monitoring (isCGM), also known as flash CGM, in individuals with T2D and recent MI, treated with insulin and/or a sulphonylurea before hospital admission. The primary outcome measure was time in range (TIR) (glucose 3.9–10 mmol/L/day) on days 76–90 post-randomization. Secondary and exploratory outcomes included time in hypoglycemia, hemoglobin A1c (HbA1c), clinical outcome, quality of life (QOL), and cost effectiveness. RESULTS: Of 141 participants randomly assigned (median age 63 years; interquartile range 53, 70), 73% of whom were men, isCGM was associated with increased TIR by 17 min/day (95% credible interval −105 to +153 min/day), with 59% probability of benefit. Users of isCGM showed lower hypoglycemic exposure (<3.9 mmol/L) at days 76–90 (−80 min/day; 95% CI −118, −43), also evident at days 16–30 (−28 min/day; 95% CI −92, 2). Compared with baseline, HbA1c showed similar reductions of 7 mmol/mol at 3 months in both study arms. Combined glycemic emergencies and mortality occurred in four isCGM and seven SMBG study participants. QOL measures marginally favored isCGM, and the intervention proved to be cost effective. CONCLUSIONS: Compared with SMBG, isCGM in T2D individuals with MI marginally increases TIR and significantly reduces hypoglycemic exposure while equally improving HbA1c, explaining its cost effectiveness. Studies are required to understand whether these glycemic differences translate into longer-term clinical benefit. [ABSTRACT FROM AUTHOR]

Published
2023
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29. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection

Author

Neoptolemos, John P., Stocken, Deborah D., Bassi, Claudio, Ghaneh, Paula, Cunningham, David, Goldstein, David, Padbury, Robert, Moore, Malcolm J., Gallinger, Steven, Mariette, Christophe, Wente, Moritz N., Izbicki, Jakob R., Friess, Helmut, Lerch, Markus M., Dervenis, Christos, Olah, Attila, Butturini, Giovanni, Doi, Ryuichiro, Lind, Pehr A., Smith, David, Valle, Juan W., Palmer, Daniel H., Buckels, John A., Thompson, Joyce, McKay, Colin J., Rawcliffe, Charlotte L., and Buchler, Markus W.

Subjects
Fluorouracil -- Comparative analysis, Gemcitabine -- Comparative analysis, Gemcitabine -- Health aspects, Pancreatic cancer -- Drug therapy, Postoperative care -- Methods, Cancer -- Care and treatment, Cancer -- Patient outcomes
Abstract

A study was conducted to evaluate and compare the safety and efficacy of adjuvant chemotherapy treatment with fluorouracil plus folinic acid as against gemcitabine following pancreatic cancer resection. Results indicated that treatment with fluorouracil plus folinic acid was found to be more effective than gemcitabine in improving outcomes in the case of such patients.

Published
2010

30. Response to Comment on Little et al. Recovery of Hypoglycemia Awareness in Long-standing Type 1 Diabetes: A Multicenter 2 × 2 Factorial Randomized Controlled Trial Comparing Insulin Pump With Multiple Daily Injections and Continuous With Conventional Glucose Self-monitoring (HypoCOMPaSS). Diabetes Care 2014;37: 2114–2122

Author

Little, Stuart A., Leelarathna, Lalantha, Walkinshaw, Emma, Kai Tan, Horng, Chapple, Olivia, Lubina-Solomon, Alexandra, Chadwick, Thomas J., Barendse, Shalleen, Stocken, Deborah D., Brennand, Catherine, Marshall, Sally M., Wood, Ruth, Speight, Jane, Kerr, David, Flanagan, Daniel, Heller, Simon R., Evans, Mark L., and Shaw, James A.M.

Published
2014
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31. Recovery of Hypoglycemia Awareness in Long-standing Type 1 Diabetes: A Multicenter 2 × 2 Factorial Randomized Controlled Trial Comparing Insulin Pump With Multiple Daily Injections and Continuous With Conventional Glucose Self-monitoring (HypoCOMPaSS)

Author

Little, Stuart A., Leelarathna, Lalantha, Walkinshaw, Emma, Tan, Horng Kai, Chapple, Olivia, Lubina-Solomon, Alexandra, Chadwick, Thomas J., Barendse, Shalleen, Stocken, Deborah D., Brennand, Catherine, Marshall, Sally M., Wood, Ruth, Speight, Jane, Kerr, David, Flanagan, Daniel, Heller, Simon R., Evans, Mark L., and Shaw, James A.M.

Published
2014
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34. Use of proton pump inhibitors to treat persistent throat symptoms: Multicentre, double blind, randomised, placebo controlled trial

Author

O’Hara, James, Stocken, Deborah D., Watson, Gillian C., Fouweather, Tony, McGlashan, Julian, Mackenzie, Kenneth, Carding, Paul, Karagama, Yakubu, Wood, Ruth, Wilson, Janet A., O’Hara, James, Stocken, Deborah D., Watson, Gillian C., Fouweather, Tony, McGlashan, Julian, Mackenzie, Kenneth, Carding, Paul, Karagama, Yakubu, Wood, Ruth, and Wilson, Janet A.

Abstract

Objective. To assess the use of proton pump inhibitors (PPIs) to treat persistent throat symptoms. Design. Pragmatic, double blind, placebo controlled, randomised trial. Setting. Eight ear, nose, and throat outpatient clinics, United Kingdom. Participants. 346 patients aged 18 years or older with persistent throat symptoms who were randomised according to recruiting centre and baseline severity of symptoms (mild or severe): 172 to lansoprazole and 174 to placebo. Intervention. Random blinded allocation (1:1) to either 30 mg lansoprazole twice daily or matched placebo twice daily for 16 weeks. Main outcome measures. Primary outcome was symptomatic response at 16 weeks measured using the total reflux symptom index (RSI) score. Secondary outcomes included symptom response at 12 months, quality of life, and throat appearances. Results. Of 1427 patients initially screened for eligibility, 346 were recruited. The mean age of the study sample was 52.2 (SD 13.7) years, 196 (57%) were women, and 162 (47%) had severe symptoms at presentation; these characteristics were balanced across treatment arms. The primary analysis was performed on 220 patients who completed the primary outcome measure within a window of 14-20 weeks. Mean RSI scores were similar between treatment arms at baseline: lansoprazole 22.0 (95% confidence interval 20.4 to 23.6) and placebo 21.7 (20.5 to 23.0). Improvements (reduction in RSI score) were observed in both groups—score at 16 weeks: lansoprazole 17.4 (15.5 to19.4) and placebo 15.6 (13.8 to 17.3). No statistically significant difference was found between the treatment arms: estimated difference 1.9 points (95% confidence interval −0.3 to 4.2 points; P=0.096) adjusted for site and baseline symptom severity. Lansoprazole showed no benefits over placebo for any secondary outcome measure, including RSI scores at 12 months: lansoprazole 16.0 (13.6 to 18.4) and placebo 13.6 (11.7 to 15.5): estimated difference 2.4 points (−0.6 to 5.4 points). Conclusions.

Published
2021

35. A randomised, placebo controlled trial of extra-oesophageal reflux treatment in the management of upper respiratory symptoms [TOPPITS:Trial of Proton Pump Inhibitors in Throat Symptoms]

Author

O’Hara, James, Stocken, Deborah D., Watson, Gillian C., Fouweather, Tony, McGlashan, Julian, MacKenzie, Kenneth, Carding, Paul, Karagama Yakubu, Wood, Ruth, Wilson, Janet A., O’Hara, James, Stocken, Deborah D., Watson, Gillian C., Fouweather, Tony, McGlashan, Julian, MacKenzie, Kenneth, Carding, Paul, Karagama Yakubu, Wood, Ruth, and Wilson, Janet A.

Abstract

Background. Persistent throat symptoms, such as throat clearing, globus sensation, voice change and catarrh are extremely common. On very limited evidence, they are increasingly attributed to “laryngopharyngeal reflux (LPR)” and treated with proton pump inhibitors (PPIs) in primary and secondary care. Methods. A double blind placebo controlled UK multicentre phase III trial randomly allocated adults with persistent throat symptoms 1:1 to either 30 mg of Lansoprazole or matched placebo twice daily for 16 weeks, stratified by centre and symptom severity. The primary outcome was patient-reported symptomatic response, measured by the total Reflux Symptom Index (RSI) score at the end of therapy. Secondary outcomes included safety, further symptoms and quality of life measures at 12-months. Results. 346 participants were randomised from 8 UK centres: mean (sd) age 52 (13), 196 (57%) female, 162 (47%) severe symptoms, balanced across randomised groups. Mean RSI scores (95% CI) were similar at baseline- Lansoprazole: 22.0 (20.4, 23.6), placebo: 21.7 (20.5, 23.0). Improvements (reduction in score) were observed in both groups at 16-weeks: Lansoprazole: 17.4 (15.5, 19.4), placebo: 15.6 (13.8, 17.3) (p=0.096 adjusted by site, severity). There was no statistically significant difference between randomised groups. No significant differences were observed in the secondary outcome measures. Conclusions. TOPPITS is the largest, definitive trial to assess PPI effectiveness for persistent throat symptoms. It found no advantage of Lansoprazole over placebo in a range of outcomes. The near routine use of PPIs for throat symptoms should be discontinued.

Published
2021

36. Lansoprazole for persistent throat symptoms in secondary care: The TOPPITS RCT

Author

Wilson, Janet A., Stocken, Deborah D., Watson, Gillian C., Fouweather, Tony, McGlashan, Julian, MacKenzie, Kenneth, Carding, Paul, Karagama Yakubu, Harries, Meredydd, Ball, Stephen, Khwaja, Sadie, Costello, Declan, Wood, Ruth, Lecouturier, Jan, O’Hara, James, Wilson, Janet A., Stocken, Deborah D., Watson, Gillian C., Fouweather, Tony, McGlashan, Julian, MacKenzie, Kenneth, Carding, Paul, Karagama Yakubu, Harries, Meredydd, Ball, Stephen, Khwaja, Sadie, Costello, Declan, Wood, Ruth, Lecouturier, Jan, and O’Hara, James

Abstract

Background: Persistent throat symptoms are commonly attributed to ‘laryngopharyngeal reflux’. Despite a limited evidence base, these symptoms are increasingly being treated in primary care with proton pump inhibitors. Objective: To assess the value of proton pump inhibitor therapy in patients with persistent throat symptoms. Design: This was a double-blind, placebo-controlled, randomised Phase III trial. Setting: This was a multicentre UK trial in eight UK ear, nose and throat departments. Participants: A total of 346 participants aged ≥ 18 years with persistent throat symptoms and a Reflux Symptom Index score of ≥ 10, exclusive of the dyspepsia item, were recruited. Intervention: Random allocation (1 : 1 ratio) to either 30 mg of lansoprazole twice daily or matched placebo for 16 weeks. Main outcome measure: Symptomatic response (i.e. total Reflux Symptom Index score after 16 weeks of therapy). Results: A total of 1427 patients were screened and 346 were randomised. The mean age was 52 years (standard deviation 13.7 years, range 20–84 years); 150 (43%) participants were male and 196 (57%) were female; 184 (53%) participants had a mild Reflux Symptom Index minus the heartburn/dyspepsia item and 162 (47%) had a severe Reflux Symptom Index minus the heartburn/dyspepsia item. A total of 172 patients were randomised to lansoprazole and 174 were randomised to placebo. Main outcomes: A total of 267 participants completed the primary end-point visit (lansoprazole, n = 127; placebo, n = 140), of whom 220 did so between 14 and 20 weeks post randomisation (‘compliant’ group); 102 received lansoprazole and 118 received placebo. The mean Reflux Symptom Index scores at baseline were similar [lansoprazole 22.0 (standard deviation 8.0), placebo 21.7 (standard deviation 7.1), overall 21.9 (standard deviation 7.5)]. The mean Reflux Symptom Index scores at 16 weeks reduced from baseline in both groups [overall 17.4 (standard deviation 9.9), lansoprazole 17.4 (standard deviation 9.9)

Published
2021

39. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer

Author

Neoptolemos, John P., Stocken, Deborah D., Bassi, Claudio, Dunn, Janet A., Hickey, Helen, Beger, Hans, Fernandez-Cruz, Laureano, Dervenis, Christos, Locaine, Francois, Falconi, Massimo, Pederzoli, Paolo, Lacaine, Francois, Spooner, David, Kerr, David J., Buchler, Markus, and Pap, Akos

Subjects
Clinical trials -- Practice, Pancreatic cancer -- Research, Pancreatic cancer -- Care and treatment
Abstract

The final results of the European Study Group for Pancreatic Cancer 1 Trial are reported and the interim results are updated. It is concluded that adjuvant chemotherapy has a significant survival benefit in patients with resected pancreatic cancer, whereas adjuvant chemoradiotherapy has a deleterious effect on survival.

Published
2004

41. Lansoprazole for persistent throat symptoms in secondary care: the TOPPITS RCT

Author

Wilson, Janet A, primary, Stocken, Deborah D, additional, Watson, Gillian C, additional, Fouweather, Tony, additional, McGlashan, Julian, additional, MacKenzie, Kenneth, additional, Carding, Paul, additional, Karagama, Yakubu, additional, Harries, Meredydd, additional, Ball, Stephen, additional, Khwaja, Sadie, additional, Costello, Declan, additional, Wood, Ruth, additional, Lecouturier, Jan, additional, and O’Hara, James, additional

Published
2021
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42. Long Term Outcomes and Exploratory Analyses of the Randomised Phase 3 BILCAP Study

Author

Bridgewater, John, primary, Fletcher, Peter, additional, Palmer, Daniel, additional, Malik, Hassan, additional, Prasad, Raj, additional, Mirza, Darius, additional, Anthoney, Alan, additional, Corrie, Pippa, additional, Falk, Steven, additional, Finch-Jones, Meg, additional, Wasan, Harpreet, additional, Ross, Paul, additional, wall, lucy, additional, Wadsley, Jonathan, additional, Evans, Jeff, additional, Stocken, Deborah D., additional, Stubbs, Clive, additional, Praseedom, Raaj, additional, Ma, Yuk Ting, additional, Davidson, Brian, additional, Neoptolemos, John, additional, Iveson, Tim, additional, Cunningham, David, additional, Garden, James, additional, Valle, Juan, additional, and Primrose, John, additional

Published
2021
Full Text
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43. Rationale and design of the LIBERATES trial: Protocol for a randomised controlled trial of flash glucose monitoring for optimisation of glycaemia in individuals with type 2 diabetes and recent myocardial infarction

Author

Everett, Colin C, primary, Reynolds, Catherine, additional, Fernandez, Catherine, additional, Stocken, Deborah D, additional, Sharples, Linda D, additional, Sathyapalan, Thozhukat, additional, Heller, Simon, additional, Storey, Robert F, additional, and Ajjan, Ramzi A, additional

Published
2020
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44. Effect of Levothyroxine on Left Ventricular Ejection Fraction in Patients With Subclinical Hypothyroidism and Acute Myocardial Infarction

Author

Jabbar, Avais, primary, Ingoe, Lorna, additional, Junejo, Shahid, additional, Carey, Peter, additional, Addison, Caroline, additional, Thomas, Honey, additional, Parikh, Jehill D., additional, Austin, David, additional, Hollingsworth, Kieren G., additional, Stocken, Deborah D., additional, Pearce, Simon H. S., additional, Greenwood, John P., additional, Zaman, Azfar, additional, and Razvi, Salman, additional

Published
2020
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48. LIBERATES_Protocol_Publication_Supp_Appendix_V2_0_Submitted – Supplemental material for Rationale and design of the LIBERATES trial: Protocol for a randomised controlled trial of flash glucose monitoring for optimisation of glycaemia in individuals with type 2 diabetes and recent myocardial infarction

Author

Everett, Colin C, Reynolds, Catherine, Fernandez, Catherine, Stocken, Deborah D, Sharples, Linda D, Thozhukat Sathyapalan, Heller, Simon, Storey, Robert F, and Ajjan, Ramzi A

Subjects
FOS: Clinical medicine, 111199 Nutrition and Dietetics not elsewhere classified, Cardiology, 110323 Surgery, FOS: Health sciences, 110306 Endocrinology
Abstract

Supplemental material, LIBERATES_Protocol_Publication_Supp_Appendix_V2_0_Submitted for Rationale and design of the LIBERATES trial: Protocol for a randomised controlled trial of flash glucose monitoring for optimisation of glycaemia in individuals with type 2 diabetes and recent myocardial infarction by Colin C Everett, Catherine Reynolds, Catherine Fernandez, Deborah D Stocken, Linda D Sharples, Thozhukat Sathyapalan, Simon Heller, Robert F Storey and Ramzi A Ajjan in Diabetes & Vascular Disease Research

Published
2020
Full Text
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